Outline of this Book

Chapter 1 introduces the challenge of the development of microbial pest control products and microbial control. The history of the concept of microbial control is presented and the industrial product developments over time. The need for a roadmap to develop biopesticides is proposed in order to provide successful products in the market. The aim of this book is to present a model that guides product developers towards a successful project. The terminology used is provided. The groups of insect pathogens used in microbial plant protection products are presented: bacteria, fungi, baculoviruses, and entomopathogenic nematodes. Finally, an outline of the chapters in this book is given.

Chapter 2 discusses the exploratory phase of finding a new microbial pest control agent, and the actual screening phase of species and strains of collected ento-mopathogenic microorganisms. Crucial characteristics of each type of pathogen relevant to their utility as a crop protection product are noted. Three decisive selection criteria will be identified. The importance of various biological parameters related to these criteria is discussed. Testing methods will be critically reviewed and recommendations for standardization of methods and test conditions will be presented. The consecutive steps in the screening process will be listed with emphasis on economic considerations.

Chapter 3 deals with the mass production and product development of a microbial pest control agent. Mass production is reviewed for each category of pathogen and the economic feasibility of mass production systems is identified. The vital issues in downstream processing, medium optimization, equipment, and inoculum stability are examined and recommendations are provided for a cost-effective mass production. Four functions of formulation are identified, formulation requirements are analyzed, and recommendations are provided for each type of pathogen. The economics of mass production and the end-use product are analyzed and a cost price model will be presented. Finally, key factors are determined for successful production and product development, and recommendations are reported to achieve optimal production, formulation and end-use product.

Chapter 4 covers quality control of the production process and the final product, with emphasis on the latter. A manufacturer establishes product specifications and these are checked for every batch. Pivotal aspects of product control are discussed for each type of pathogen. Registration requirements are reviewed. Complete quality control procedures and data for validation must be established, although there are no officially recognized criteria. Practical challenges in quality control procedures are reviewed per type of pathogen. Recommendations for standardization and criteria will be provided. Research needs are identified that may facilitate quality control in the future. The benefits of quality control for the manufacturer and the end-user will be identified.

Chapter 5 reports on regulations related to the use of microbial pest control agents and products. Microorganisms are subject to registration as a "plant protection product" (PPP), whereas nematodes are usually covered by different regulations. Registration requirements are reviewed, particularly for the European Union. For several topics, data requirements are unclear or even lacking; procedures are both long and expensive. Initiatives to ameliorate these impediments are reviewed. Various other regulations, such as laws on biodiversity, importation and release of exotic organisms, and safe handling, apply to the use of microorganisms, and are briefly treated. Intellectual property rights are important for a company. The possibility to obtain a patent for a biopesticide and the value thereof will be discussed. Regulations form a major obstacle in the commercialization of biopesticides, and improvements and recommendations are provided to facilitate the approval processes in the future. The role that the biocontrol industry should have in this political field is outlined.

Chapter 6 presents key factors to cost-effective implementation of a microbial pest control product, namely the application strategy, compatibility, and knowledge transfer to the user. This requires the design of a comprehensive integrated pest management programme in which the microbial pest control product is to be incorporated. The first element is an optimal application strategy per targeted pest and cropping system. The second element is the incorporation of the micro-bial pest control product in an IPM system. Compatibility with chemical pesticides and with beneficial organisms must be established and critical aspects will be mentioned for each type of pathogen. The risk of resistance will be briefly discussed. Adoption of new products needs knowledge transfer in the entire supply chain to the grower, and pivotal considerations including economic aspects will be reviewed. Requirements and recommendations will be provided on how to accomplish a successful implementation. Some considerations will be presented with regard to the compatibility profile, the advantages and the disadvantages of biopesticides, the cost of the implementation process, and to the potential of combined use of biopesticides.

Chapter 7 reviews the critical factors in the successful commercialization of microbial pest control products. The history of the biopesticide industry will be highlighted. Currently available products will be presented, as well the biopesticide markets in Europe and the Netherlands. The main crops in which biopesticides are used are presented as well as the most successful products. Profitability of products in relation to their market size will be analyzed. Critical success and failure factors for a biopesticide company and for a microbial pest control product are analyzed, and recommendations will be provided on essential factors that need to be considered. Tools will be provided to facilitate decision-making in the commercialization process. Company profiles will be reviewed, and a business model will be identified that currently performs best. An estimate of the developmental time and costs for a microbial pest control product is provided. The distribution and sale strategy is reviewed, and various salient options are discussed. Crucial factors will be identified, and recommendations will be provided that will increase the chances to develop a successful biopesticide and to become a profitable and sustainable biopesticide company.

Chapter 8 provides a roadmap to success, and future prospects for use of microbial control products. The roadmap to successful development and commercialization of a microbial pest control product is amply illustrated in newly designed flow diagrams. Diagrams are presented for the screening phase, the product development phase, and the implementation phase. Relevant input criteria and requirements are provided. Output information leads to consecutive steps and "go/no go"-decisions. A future perspective on the biopesticide market is presented with limiting and promoting factors and trends. The most important drivers are concerns about food safety and the environment, new research and technology, changes in the regulatory climate, and the arrival of exotic pests. The biopesticide industry has reached a level of maturity and critical mass that forms a solid base for further expansion. The future of the market size and growth is estimated, and an outlook of the way forward is presented.

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